Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062087) titled 'Efficacy study on the effects of erythritol-containing gel application after toothbrushing on oral bacteria' on June 29.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Biosys Lab Co., Ltd.

Condition: Condition - Healthy Adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To exploratorily evaluate the oral environment-improving effect of a single application of erythritol-containing gel after regular toothbrushing before bedtime, compared with non-application, in a crossover study. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Group I: In Period 1, a single application of approximately 15 g of the test food (5% erythritol-containing gel, equivalent to 0.5-0.8 g of erythritol) into the oral cavity after regular toothbrushing before bedtime. Following a 1-week washout period, Period 2 consists of non-application of the product (regular toothbrushing only). Interventions/Control_2 - Group II: In Period 1, non-application of the product (regular toothbrushing only). Following a 1-week washout period, Period 2 consists of a single application of approximately 15 g of the test food (5% erythritol-containing gel, equivalent to 0.5-0.8 g of erythritol) into the oral cavity after regular toothbrushing before bedtime.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1. Persons who received a sufficient explanation of the purpose and contents of the study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate. 2. Japanese male or female aged 18 years old or more and under 70 years old at the time of obtaining consent. 3. Persons who do not have an allergy to artificial sweeteners such as erythritol. 4. Persons who do not suffer from diseases related to the oral cavity, teeth, or gums (not diagnosed with alveolar pyorrhea or periodontal disease), and feel concerned about their oral environment but are judged not to need immediate treatment. Key exclusion criteria - 1. Persons who are diagnosed with oral diseases such as alveolar pyorrhea or periodontal disease, or who are scheduled for dental treatment on the day of the study. 2. Persons who routinely use (3 days or more per week) products containing artificial sweeteners such as erythritol, or who have routinely used them within 3 months prior to the pre-examination. 3. Persons who are diagnosed with malignant tumor, or who are undergoing treatment for cranial nerve disease, heart disease, kidney disease, diabetes, or thyroid dysfunction, or who have a history of serious diseases such as liver disease. (However, diseases such as hypertension treatment which the principal investigator judges not to affect the evaluation of this study are excluded.) 4. Persons who consume a large amount of alcohol (60 g or more of alcohol per day: equivalent to approximately 1500 mL of beer, 540 mL of wine, 3 go of sake, or 180 mL of double whiskey). 5. Persons who may develop an allergic reaction related to the study product. 6. Persons who are judged to be inappropriate as a study subject based on their response to the background survey. 7. Persons who have participated in another clinical study within 1 month before obtaining consent for this study, or who plan to participate in another clinical study after consenting to this study. 8. Persons who are pregnant, planning or hoping to be pregnant during the study period, or breastfeeding. 9. Persons who are otherwise judged as inappropriate for study participants by the principal investigator. Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 26 Day Date of IRB - 2026 Year 06 Month 24 Day Anticipated trial start date - 2026 Year 06 Month 29 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071002

Disclaimer: Curated by HT Syndication.